CN101080195A

CN101080195A - Pacifier system and method for studying and stimulating the human orofacial system

Info

Publication number: CN101080195A
Application number: CNA2005800361935A
Authority: CN
Inventors: S·M·巴洛; D·S·菲南
Original assignee: University of Kansas; University of Colorado
Current assignee: University of Kansas; University of Colorado
Priority date: 2004-08-30
Filing date: 2005-08-29
Publication date: 2007-11-28
Anticipated expiration: 2025-08-29
Also published as: US8251926B2; EP1786319B1; WO2006026623A3; ES2396552T3; WO2006026623A2; US20060074354A1; EP1786319A2; CN101080195B

Abstract

The topic of the invention is suitable to evaluate the biomechanics and electrophysiology of the mouth-and-face systems of the infant when it is in suction course. The invention includes at least one mouth-and-surface sensor, a processor, a false nipple (110) with a bag (112), a receiver component (106), a stimulation acting device (134), a memorizer (126), a display apparatus (136) and a digital data obtaining and analyzing software. Advantageously, the topic can non-invasively collect and analyze the suction and can stimulate the nerve endings of the infant face.

Description

Be used to study Pacifier system and method with the stimulating human orofacial system

Requirement is in the rights and interests of first to file

Present patent application requires the rights and interests of following application: submit on August 30th, 2004, serial number is No.60/605,607 U.S. Provisional Application, and submit on August 22nd, 2005, attorney docket is No.1628.004US1, autograph is included the full content of these two pieces of applications in this description in this mode by reference for the U.S. Patent application of " Pacifier System forStudying and Stimulating the Human Orofacial System ".

Relevant international application

The application relates to same day (the attorney docket No.1628.005WO1) that submit to, autograph is included its full content in this description in this mode by reference for the international patent application of " Pacifier System for Stimulating and Entraining the HumanOrofacial System ".

About the federal funding research and development following do the invention rights statement

The theme of being discussed in the present patent application, part are subsidized for the American fund of No.R01-DC03311-01 by NIH (NIH) fund number.Government can be to having certain right at this theme of discussing.

Technical field

Present patent application totally belongs to the system and method that is used to estimate animal, more specifically, belongs to the system and method that is used to study with the stimulating human orofacial system.

Background technology

Typical human foetus's the brain per minute of growing increases thousands of neurons.During fetal development and when birth, neurocyte and concrete nervous function interrelate.Therefore the brain of ewborn infant is grown neuron-nervous function contact according to postnatal experience.

In premature labor, premature infant has lost and carried out neurodevelopmental chance safely in the uterus.What follow this forfeiture may be the medical complication relevant with premature labor, such as apoplexy or hemorrhage.In addition, the treatment of medical complication usually is accompanied by painful process, and this painful process is relevant with the function damage in the neurodevelopment.Each pressure in these pressure can influence independently sucking, swallow or respiration capability of premature infant.Such function damage can influence the growth of intelligence and session.

Hundreds and thousands of babies of the annual influence of this problem of the U.S..Have among these babies and much suffering the partly puzzlement of nervous system, respiratory system and/or its hetero-organization of growth.Fortunately, because brain is in people's lasting in life growth, so can overcome impaired neutral net by early discovery and treatment.Yet, have much and can not find in these nervous function damages and the dysplasia by existing diagnostic tool.Necessary is to have new instrument earlier to differentiate problem.

Summary of the invention

By reading and study this description, there not be the problem of special argumentation at this with understanding by the problems referred to above that this theme proposed and other.

An embodiment of this theme comprises: bag; Be suitable for detecting a plurality of actinal surface pick offs that at least one is sucked signal and also is suitable for detecting at least one facial muscle tissue signal; And at least one sucks the processor of signal and this at least one facial muscle tissue signal to be suitable for receiving this, and wherein this processor is suitable for based on this at least one and sucks signal and this at least one facial muscle tissue signal and calculate and suck profile and represent.

The other embodiments of this theme comprise electrode type actinal surface pick off.Some embodiments comprise the actinal surface pick off, and this actinal surface pick off is a pressure converter.In some embodiments, the first actinal surface pick off is pneumatic to be connected to by the determined bag mouth of bag, and wherein this first actinal surface pick off is suitable for detecting and sucks signal.In some embodiments, this electrode is positioned at bag pedestal to detect the facial muscle tissue signal of this subject.Some embodiments comprise the receiver assembly between this bag and this first actinal surface pick off.

In some embodiments, this processor is suitable for utilizing at least in part this to suck that profile is represented and the profile of sucking of being scheduled to is calculated and sucked defective and represent.Some embodiments comprise at least one memory storage apparatus, this memory storage apparatus be suitable for storing this at least one suck signal, this at least one facial muscle tissue signal, this is sucked, and profile represents, sucks that defective is represented, the historical record of a kind of or its combination in boosting control signal, force signal and the displacement signal.

In a plurality of embodiments, stimulate control module to be suitable for providing boosting control signal, this boosting control signal is sucked defective based on this at least in part and is represented that wherein this boosting control signal is used to regulate or start the stimulation that offers this subject.Some embodiments comprise the stimulation device, and this stimulation device comprises the motor that is suitable for boosting control signal is converted to mechanical activity; And the stimulation utmost point that is mechanically connected to this motor, this stimulation utmost point is suitable for introducing this mechanical activity to the orofacial system of this subject.In some embodiments, this motor comprises that further at least one is suitable for providing a kind of in force signal and the displacement signal or both stimulation device pick offs.

In a plurality of embodiments, this theme comprise be suitable for showing in real time bright this at least one facial muscle tissue signal, this suck profile represent, suck defective is represented and boosting control signal in a kind of display device of or its combination.

Another embodiment of this theme comprises and is connected to bag with sucking pick off; This is sucked pick off be connected to shell; At least one actinal surface pick off is connected to this shell; Force feedback stimulation device is connected to this shell; And in this shell, with processor and this stimulation device, this sucks pick off and this at least one actinal surface pick off is interconnected, this processor has memorizer.

The general introduction of some instructions that this summary is the application does not intend to become the exclusive or exhaustive processing of this theme.About the more details of this theme can find in detailed description and appended claims.By reading and understanding following detail specifications and check the figure that constitutes this description part, other aspects will be readily apparent to persons skilled in the art, and the not conditional meaning of description and figure.Scope of the present invention is determined by appended claims and legal equivalent thereof.

Description of drawings

In the accompanying drawings, there is no need to draw in proportion, but the like in all different views is represented with same figure notation.Accompanying drawing as an example, rather than as restriction, a plurality of embodiments that illustrate among the application on the whole to be discussed.

Fig. 1 is the part side view with tangent plane, illustrates the system that is used to study patient with first 500 and second portion 600 according to an embodiment of this theme;

Fig. 2 is the sketch map that illustrates a plurality of parts of the system that at least one embodiment according to this theme constitutes;

Fig. 3 A is the axonometric chart that illustrates the part of the system that at least one embodiment according to this theme constitutes;

Fig. 3 B be illustrate among Fig. 3 A the front view of a part of diagrammatic system;

Fig. 3 C is the cross-sectional view along Fig. 3 B line 3C-3C intercepting, illustrates the part of the system that at least one embodiment according to this theme constitutes;

Fig. 4 is the axonometric chart that illustrates the assembly of the system that at least one embodiment according to this theme constitutes;

Fig. 5 A is the performance chart that illustrates the element of the system that at least one embodiment according to this theme constitutes;

Fig. 5 B is the performance chart that illustrates the element of the system that at least one embodiment according to this theme constitutes;

Fig. 6 A is the collected data and curves figure of system that illustrates according at least one embodiment formation of this theme;

Fig. 6 B is the collected data and curves figure of system that illustrates according at least one embodiment formation of this theme;

Fig. 7 is the flow chart that illustrates the method that at least one embodiment according to this theme constitutes.

The specific embodiment

The following detailed description of this theme relates to the theme in the accompanying drawing, and this accompanying drawing shows concrete aspect and the embodiment that can implement this theme therein with way of illustration.These embodiments are fully at length described so that those skilled in the art can implement this theme." one " who is mentioned in the disclosure, " one " or " a plurality of " embodiment needn't be meant identical embodiment, and such reference marker is expected a more than embodiment.Ensuing detailed description is the exemplary and hard-core meaning.The scope of this theme is determined by the four corner of the legal equivalents that claims and this claim are authorized.

Fig. 1 is the part side view with tangent plane, illustrates having being used for and the patient interaction system of first 500 and second portion 600 according to the embodiment of this theme.In a plurality of embodiments, native system is suitable for studying the biomechanics and the electrophysiology of baby's orofacial system during no nutrition is sucked.Yet this theme also is suitable for studying other biomechanics and electrophysiology.In a plurality of embodiments, system 100 comprises in order to shell 102 that holds motor 104 grades and receiver assembly 106.In a plurality of embodiments, what link to each other with motor 104 can be to stimulate the utmost point (stimulus applicator) 134.In some instances, between the stimulation utmost point 134 and receiver assembly 106, can there be adjustable size relationship.For example, some embodiments use the bigger stimulation utmost point 134 to be equipped with littler receiver assembly 106.Other embodiments make the littler stimulation utmost point 134 be equipped with bigger receiver assembly 106.

In a plurality of examples, receiver assembly 106 is equipped with the actinal surface pick off, such as sucking pick off, to detect the signal of sucking from the baby.In a plurality of examples, receiver assembly 106 is applicable to that by means of the cannelure structure false nipple 110 removably connects.In an example, the false nipple 110 that is used for system 100 is medical silicon nipples, such as the false nipple of SOOTHIE.SOOTHIE be child's medical product company limited of being built up in the Delaware State (Children ' sMedical Ventures, registered trade mark Inc.).The structure of other false nipples and model also fall in the scope of this theme.A plurality of embodiments are used the available false nipple of at least three kinds of sizes: miniature premature infant, premature infant and full-term newborn infant.

In some instances, false nipple 110 comprises the bag 112 with bag mouth 114 and bag pedestal 116.In some instances, false nipple 110 also comprises bag chamber 118.In some instances, suck that pick off and bag mouth 114 are pneumatic to be connected when being inserted in baby's mouth when false nipple, detect the signal of sucking from the baby.Suck a plurality of examples of pick off in this argumentation.In a plurality of examples, system 100 comprises one or more actinal surface pick offs, such as the facial muscle tissus sensor, to detect one or more facial muscle tissue signals from the baby.In some instances, one or more pick offs comprise the electrode that is located on or near bag pedestal 116 places separately.Discuss a plurality of examples of facial muscle tissus sensor at this.

A plurality of examples of this theme comprise processor 122, and processor 122 can coexist with timing circuit.In an example, processor 122 with suck sensor electrical and be connected with reception and suck signal, and be electrically connected to receive one or more facial muscle tissue signals with each facial muscle tissus sensor 120.In some instances, sucked signal and facial muscular tissue signal before being transmitted to processor 122, at first all receive by detecting detection circuit 124.In a plurality of examples, processor 122 utilization is sucked signal and facial muscular tissue signal and is calculated to execute instruction and suck profile and represent.In some instances, processor 122 only utilizes the facial muscle tissue signal to calculate to execute instruction to suck profile and represents.

In a plurality of embodiments, suck profile represented to provide can with the summary of the predetermined baby's who sucks the profile comparison the ability of sucking.In some embodiments, suck profile and comprised sucking and facial muscular tissue signal of being detected in representing.A plurality of embodiments provide one or more int babies' of nervous system that are of the similar age the profile of sucking to represent.For example, some embodiments provide and have been used for not suffering nervous function damage or stunted baby's the profile of sucking to represent.

In a plurality of examples, processor 122 is sucked profile represents except calculating, and also execution command is calculated and sucked defective and represent.In some instances, sucking defective represents be to utilize and sucks profile and represent predetermined to suck that profile calculates with one or more.In a plurality of examples, one or more predetermined sucking in the memorizer 126 that profile is stored in processor 122.In some instances, one or more predetermined profiles of sucking are transmitted to memorizer 126 by external user interface 128.In a plurality of embodiments, external user interface 128 provides input equipment for the user and communicates to connect with processor 122.

In a plurality of examples, processor 122 is electrically connected to stimulates control module 130.In a plurality of embodiments, stimulate control module 130 to be configured to represent to regulate or start stimulation based on the defective of calculating by processor 122 of sucking.Some embodiments comprise reinforcement (punctuate) mechanical stimulus.Stimulate control module 130 to stimulate by generating boosting control signal and regulating or start.In a plurality of embodiments, stimulate control module 130 to send boosting control signal to output circuit 132.In a plurality of examples, in case output circuit 132 receives boosting control signal, output circuit 132 and then starter 104.In a plurality of examples, the telecommunication that motor 104 receives from output circuit 132 is a mechanical activity with such transition of communications also.In an example, motor 104 is the linear motors that telecommunication are transformed into one or more linear displacements.In some instances, the stimulation utmost point 134 is mechanically connected to motor 104 and introduces mechanical activity to baby's face.One type mechanical activity is displacement, but the mechanical activity of other types also falls into this scope.

In a plurality of embodiments, motor 104 comprises that at least one stimulation device pick off is to detect and the relevant information of impact that stimulates 134 pairs of subject of the utmost point.In a plurality of embodiments, sensor measurement is to the impact of the face of subject.Other sensor stimulates the position of the utmost point with respect to shell 102.In a plurality of embodiments, testing circuit 124 can receive the detection information from least one stimulation device pick off.A plurality of embodiments provide detection information to processor 122.Processor 122 is suitable for analyzing and testing information and will detects information and available data of storing compare.A plurality of embodiments are utilized this detection information, improve patients'satisfaction by reducing the illeffects power that face stood.In one embodiment, this effect is that the calculating of the signal by 122 pairs of guide motors of processor 104 motion realizes.In some instances, such signal is transmitted to motor 104 by output circuit 132.This theme comprises, but be not limited to, (attorney docket No.1628.005WO1) autograph in relevant common transfer, submission in same day is included its full content in this description in this mode by reference for disclosed system in the international patent application of " Pacifier System forStimulating and Entraining the Human Orofacial System ".

A plurality of embodiments comprise one or more display 136, to present by the data of sucking data that pick off detected, being detected by facial muscle tissus sensor 120 and/or at least one stimulation device pick off.In a plurality of embodiments, display also presents the data of being analyzed by processor 122.In a plurality of embodiments, display presents the data of being imported by external user interface 128.In some embodiments, be presented on one or more display 136 data in real time as seen.

In a plurality of examples, memorizer 126 is configured to one or more predetermined profiles of sucking.In a plurality of examples, memorizer 126 is configured to also that storage is sucked signal, facial muscle tissue signal, sucked that profile represents, sucks that defective is represented, the historical record of a kind of or its combination in boosting control signal, active force information (for example, force signals) and/or the displacement information (for example displacement signal).

Fig. 2 is an embodiment that illustrates according to this theme, the sketch map with patient's measuring system 100 of first 500 and second portion 600.In a plurality of embodiments, the biomechanics and the electrophysiology of baby's orofacial system during no nutrition is sucked can be studied by system 100.In a plurality of embodiments, system comprises the actinal surface pick off, such as sucking pick off 108; Motor 104; A plurality of stimulation device pick offs 144,146; A plurality of actinal surface pick offs are such as facial muscle tissus sensor 120; And/or processor 122.In some instances, by inserting integrated line to electrical outlet, and to system's 100 power supplies.In another example, power to system 100 by one or more batteries that more motilities can be provided.Can also use other power supplys, but not break away from the scope of this theme.

In an example, suck suck the processor 122 that signal also send this signal electrical connection of pick off 108 detections from the baby.In an example, suck pick off 108 and 110 pneumatic connections of false nipple with bag 112.In a plurality of embodiments, when bag 112 is inserted in baby's the mouth and is sucked by the baby, suck pick off 108 and generate and suck signal.In a plurality of embodiments, suck amplifier 140 amplifications and suck signal so that the signal of sucking of amplification to be provided.Can to be sucked comparator 142 used for the signal of sucking that amplifies, and be digital signal from analog signal conversion.Sucking comparator 142 is suitable for the signal of sucking from the detected amplification of baby is compared with one or more predetermined profiles of sucking.As mentioned above, one or more predetermined profiles of sucking are based on observed result from the int baby of nervous system who is of the similar age.In a plurality of examples, one or more predetermined profiles of sucking are stored in the memorizer 126.Suck signal and one or more predetermined sucking after profile compares what will amplify, suck comparator 142 and can calculate and suck defective and represent.

In a plurality of embodiments, represent that based on sucking defective processor 122 executable instructions are calculated boosting control signal with starter 104, this motor is suitable for stimulating the baby.In a plurality of examples, boosting control signal is sent to motor comparator 148.In other embodiments, motor amplifier 150 amplifies boosting control signal so that the boosting control signal of amplification to be provided.In some instances, the boosting control signal of amplification moves motor 104, and making like this stimulates the utmost point to move with respect to baby's face.In a plurality of embodiments, this moves and depends on the signal that is offered processor 122 by at least one stimulation device pick off.In an example, motor 104 is the linear motors that are connected to stimulation probe.In the another one example, stimulation probe act as the stimulation utmost point.

In some embodiments, motor is suitable for allowing to be up to the track displacement of 8mm.In other embodiments, motor is suitable for allowing to be up to the track displacement of 15mm.Other track displacements also fall into the scope of this theme.The different embodiments of this theme allows at the track displacement that forces under feedback (forced feedback) condition.

In some examples of this theme, motor 104 can with a plurality of stimulation device pick offs, such as force cell 144 and differential magnetic resistance transducer (DVRT) 146, integrate.In a plurality of embodiments, force cell 144 provides the force information (for example, passing through force signal) of motor 104 by being the signal of telecommunication with force transformation.In an example, force signal is amplified by power amplifier 152, and is also used by motor comparator 148, and is digital signal from analog signal conversion.In a plurality of embodiments, motor comparator 148 with the force signal that amplifies and power threshold predetermined, pre-programmed to guarantee the stimulating utmost point 134 can not injure baby's face.In some instances, DVRT 146 is by being transformed to motor displacement the positional information that the signal of telecommunication provides motor 104.In one embodiment, positional information is based on displacement signal.In an example, displacement signal is amplified by displacement amplifier 154 and is converted into digital signal from analogue signal.

In a plurality of embodiments, the operation together of force cell 144, DVRT 146 and motor 104 makes the stimulation utmost point 134 (Fig. 1) finish drilling in force feedback and does to realize stimulating to carry and real-time force follow-up.Force feedback means that the stimulation device can be programmed with the face that follows the baby tightly accurately to introduce one or more stimulations to this face.In an example, the face that stimulates the utmost point can follow the baby in real time.This real-time tracing makes stimulates the utmost point no matter whether baby's face moves, and can both introduce accurately, effectively stimulate and carry.

In an example, a plurality of facial muscle tissus sensors 120 comprise electrode separately.In an example, electrode non-intrusion type ground detects and provides one or more facial muscle tissue signals to the processor 122 that is electrically connected.In an example, eight electrodes are divided into four signalling channels.In a plurality of embodiments, the facial muscle tissue signal is amplified by a plurality of facial muscle tissus sensor amplifiers 138, and is digital signal by one or more signal conditioners from analog signal conversion.In an example, the facial muscle tissue signal is amplified by GRASS P511 biological amplifier, this amplifier is by No. 600 (600East Greenwich Avenue in eastern Greenwich main road of the western Warwickshire of Rhode Island, West Warwick, RI 02893) the Grass Telefactor branch manufacturing of AstroMed.In an example, the facial muscle tissue signal is digital signal by 16 front end analog-to-digital conversion cards from analog signal conversion, this analog-to-digital conversion card is (the National Instruments of national Instr Ltd. by No. 11500, the provincial capital, Texas Austin's northern Mopac highway, Inc., of 11500N Mopac Expressway, Austin, TX 78759-3504) make.Also have other amplifiers and signal conditioner and do not break away from the scope of this theme.As hereinafter will more detailed argumentation, baby's brain be to baby's the behavior that face sent during facial muscle tissus sensor 120 can be used to detect and suck.

In a plurality of embodiments, processor 122 can be configured to that real-time storage is sucked signal, facial muscle tissue signal, sucked that defective is represented, the historical record of a kind of or its combination in boosting control signal and/or power and the displacement signal.In addition, in a plurality of examples, processor 122 be programmed with real-time analysis and show suck signal, facial muscle tissue signal, suck that defective is represented, a kind of or its combination in boosting control signal and/or power and the displacement signal.In a plurality of embodiments, the real-time storage of existing data, analysis and demonstration can realize by the one or more software programs that send processor 122 in a plurality of examples of system 100.In some instances, first software program is used for data and obtains purpose, and second software program is used for real-time analysis and video data.In some instances, single software program is used for the purpose that data obtain, analyze and/or show.

In an example, software program can be realized that real-time multi-channel data obtains, waveform shows and the baby is sucked biomechanics analysis.Example calculates automatically and shows in the block diagram mode to be sucked " outburst " cycle, suck amplitude and sucks stalled cycles.In a plurality of embodiments, one or more of these data are shown in real time.In addition, in a plurality of embodiments, software program can be carried out the frequency city of sucking the outburst incident and analyze (for example, Fourier transformation).In an example, software program obtained data with 30 second time cycle, and wherein the quantity in data collection cycle only is subjected to the hardware driving resource limit of PC system.The time cycle of other quantity is also within the scope of this theme.This routine software program can be from baby's all muscle of the mouth facial muscle tissue of sampling immediately, samples in the both sides that are included in the below skin part of the top of orbicularis oris and orbicularis oris.

In a plurality of embodiments, software program can be to boosting control signal, force signal, displacement signal, suck a kind of or its combination in signal and/or the facial muscle tissue signal carries out real-time multi-channel data and obtains and pictorial display.The multi-channel data of some embodiments obtains to comprise 8 passages, 16, the acquisition of 100 microsecond residence times.In a plurality of embodiments, software program carry out pre-trigger (for example 50 milliseconds) and back trigger (for example 100 milliseconds) data and obtain to suck with the no nutrition that is captured in the baby during the reflection of the facial reflex response of nervi trigeminus activate and adjusting.In a plurality of embodiments, software program is guaranteed the mechanical stimulus of baby's face is caused the facial reflection of nervi trigeminus.In addition, in a plurality of embodiments, software program according to the baby suck periodic basis in time and position aspect two control stimulate.In an example, software program can be from baby's all muscle of the mouth facial muscle tissue of sampling immediately, samples (for example, around mouth, forming the sphincter of most of lip tissue) in the both sides that are included in the below skin part of the top of orbicularis oris and orbicularis oris.In more example, this routine software program can the combine digital signal processing, comprising: according to the mechanical stimulus incident facial muscular tissue signal is gone average, correction, integration and/or signal average.

Fig. 3 A is an embodiment according to this theme, is used for the axonometric chart of first 500 of the system of monitor patients.In a plurality of embodiments, system is biomechanics and the electrophysiology that is used to study baby's orofacial system during no nutrition is sucked.Yet this theme also is suitable for studying other biomechanics and electrophysiology.In a plurality of embodiments, the first 500 of system 100 comprises shell 102 and the receiver assembly in order to hold motor 104.In a plurality of embodiments, what link to each other with motor 104 can be to stimulate the utmost point 134.In some instances, between the stimulation utmost point 134 and receiver assembly, can there be adjustable size relationship.In a plurality of examples, receiver assembly is to make it be applicable to that false nipple 110 removably connects by means of the cannelure structure.In an example, false nipple 110 comprises the bag 112 with bag mouth 114 and bag pedestal 116.In a plurality of embodiments, bag 112 is applicable to by the baby to be sucked.

In a plurality of embodiments, first 500 also comprises one or more actinal surface pick offs, such as facial muscle tissus sensor 120.In some instances, each facial muscle tissus sensor 120 can comprise electrode.As mentioned above, facial muscle tissus sensor 120 can be used to the detection of non-intrusion type ground and provide at least one facial muscle tissue signal from the baby to processor 122.In a plurality of embodiments, each all comprises electrode diagrammatic eight facial muscle tissus sensors of institute 120.In an example, eight electrodes are positioned at bag pedestal 116 and arrange circlewise with the curvature with baby's face and closely cooperate.In an example, eight electrodes can be the disks of 4mm diameter, and 4.5mm at interval each other.In another example, can contain the offset of vertical of 2mm with the electrode of baby's corners of the mouth linear array.In a plurality of embodiments, such interval can make each electrode set up with baby's face with skew and effectively communicate by letter, and therefore can guarantee to detect accurate facial muscle tissue signal.In some instances, facial muscle tissus sensor 120 is electrically connected to measuring system by the quick connection adapter 155 that quick assembly and disassembly are provided.

In a plurality of embodiments, stimulate the utmost point 134 to be mechanically connected to motor 104.In some instances, stimulating the utmost point 134 is stimulation probes.In such example, the diameter of stimulation probe is 10mm, and is connected to the Luer accessory and is used for rapid release (release).Also can use other probe diameter and accessory, and not depart from the scope of the present invention.In a plurality of examples, motor 104 receives the boosting control signal of from processor, and motor 104 is converted to mechanical activity with this boosting control signal, such as linear movement.In some instances, introduce this linear movement by stimulation probe to baby's orofacial system.In such example, the baby receives about 600-900 micron in about 10 milliseconds time cycle face is recessed into.In a plurality of examples, the beginning of this mechanical stimulus and the inclination and the pressure that are regularly cooperating the baby to suck are triggered.As mentioned above, when measuring system detects the pressure signal of sucking from the baby, and compare with one or more predetermined profiles of sucking this being sucked pressure signal, when finding that it presents defect characteristic, activate this mechanical stimulus.In response, processor can synthesize the boosting control signal that activates motor 104.

In a plurality of embodiments, send mechanical stimulus by face to the baby, can cause the neuromuscular activity by nervi trigeminus and facial cranial nerve.Particularly, when sending stimulation to baby's face, can activate as the sensory nerve ending of the unified part of trigeminal system.These are exactly usually said elementary mechanical sense neuron.Therefore, the nerve fiber in the nervi trigeminus system can be activated and be input in baby's the brain stem, and neuron is connected to baby's sensory system baby's organ of locomotion in the brain stem place.Motor neuron has cyton in baby's face nerve nuclear, in a single day these cytons receive sensory signal from sensory neuron and (fire) (for example, activate) with regard to " evoking ".In a plurality of embodiments, by utilizing one or more actinal surface pick offs, such as facial muscle tissus sensor 120, at least one facial muscle tissue signal (for example electromyogram graphy (EMG) signal) can be by the measuring system record.According to a plurality of embodiments of this theme, the musculation that excites nerve and the importance of measuring baby's reaction are: such operation provides sucks ability strong expansionary and diagnostic measurement to the baby.In addition, a plurality of embodiments provide quantitative, objectively and have repeatably measured.

In some instances, the first 500 of measuring system is suitable for by the user hand-held.In other embodiments, first 500 is suitable for and can be installed on the external device (ED).Allow measuring system 100 or relevant subassembly to detect at least one and suck a kind of or its combination in signal and at least one facial muscle tissue signal, and other support patterns that allow further to introduce stimulation to the baby also fall in the scope of this theme.

Fig. 3 B is the diagrammatic front view of Fig. 3 A.In a plurality of embodiments, the biomechanics and the electrophysiological instrument that can be used for studying baby's orofacial system during no nutrition is sucked demonstrated in this diagram.Yet this theme is applicable to research other biological mechanics and electrophysiology in addition.In a plurality of embodiments, first 500 comprises in order to hold shell 102 and the receiver assembly of motor 104 (Fig. 3 A).In a plurality of examples, false nipple 110 is detachably connected to receiver assembly.In an example, false nipple 110 comprises the bag 112 with bag mouth 114.

In an example, first 500 comprises one or more actinal surface pick offs, such as facial muscle tissus sensor 120, and stimulates the utmost point 134.In an example, eight facial muscle tissus sensors 120 are positioned on the electrode PC plate 156 in the form of a ring, and each facial muscle tissus sensor comprises electrode.In some instances, pick off is positioned on the circuit board of PC.A plurality of pick off configurations are made into the close-fitting shape of curvature with baby's face.In an example, eight facial muscle tissus sensors 120 are electrically connected to measuring system by quick connection adapter 155.In a plurality of examples, stimulate the utmost point 134 such as baby's the corners of the mouth, to introduce stimulation to baby's face.

Fig. 3 C is the cross-sectional view along Fig. 3 B line 3C-3C intercepting.According to an embodiment of this theme, this diagram shows receiver assembly 106, false nipple 110, sucks pick off 108 and a plurality of actinal surface pick off, such as facial muscle tissus sensor 120.Should be noted that except pick off 108 was sucked in utilization, other structures in this subject area also were suitable for utilizing other actinal surface pick offs.Receiver assembly 106 can be suitable for false nipple 110 and removably connect.Some embodiments of receiver assembly 106 comprise the cannelure structure.In an example, removably connect by means of comprising be connected to ball 107 intubate 105 receiver assembly 106 and become possibility.In a plurality of embodiments, intubate is stainless.Other embodiments have been included a ball that comprises the DELRIN material in.DELRIN is E.I.Du Pont Company (E.I.DuPont de Nemours and Company Corporation, 101 West 10 ^ThSt., Wilmington, DE 19898) registered trade mark.In a plurality of examples, receiver assembly is the passage of (bag) inner chamber 118 pressure conversion.In a plurality of embodiments, ball 107 has circumferential flange 109, and this flange 109 plays the guard ring effect at bag pedestal 116 or near bag pedestal 116 places to false nipple 110.In an example, false nipple 110 comprises the bag 112 with bag mouth 114 and bag pedestal 116.In an example, false nipple 110 also comprises bag chamber 118.

In a plurality of embodiments, suck pick off 108 and can detect sucking signal and sending this signal to processor from the baby.In some instances, suck pick off 108 and suck signal with 114 pneumatic connections of bag mouth with detection.In some instances, suck signal and comprise the expression of sucking intensity, sucking the persistent period and sucking a kind of or its combination in the frequency.In an example, suck pick off 108 and be arranged in bag chamber 118.In some instances, sucking pick off 108 is pressure converters, such as Honeywell International's company limited (Honeywell International Inc. by No. 101, the inferior main road of Morrison town taxi driver brother rival of New Jersey, 101 ColumbiaRoad, Morristown, NJ 07962) pressure converter made.In an example, pressure converter comprises the vent valve that has the Luer adapter.Also can use the structure and the model of other pressure converters, and not break away from the scope of this theme.Similarly, also can use other valves and adapter and do not break away from the scope of this theme.

A plurality of facial muscle tissus sensors 120 are suitable for the non-intrusion type detection and send at least one facial muscle tissue signal from the baby to processor.In some instances, each facial muscle tissus sensor 120 can comprise electrode.In some instances, each of a plurality of facial muscle tissus sensors 120 is configured to detect at least one facial muscle tissue signal.In addition, in a plurality of embodiments, each facial muscle tissus sensor 120 is configured to detect at least one and sucks signal.A plurality of embodiments of this theme do not comprise sucks pick off 108.

Fig. 4 is the axonometric chart that illustrates according to the actinal surface pick off of the embodiment of this theme.A plurality of embodiments of this theme are utilized the one or more electrophysiological actinal surface pick offs that can study the orofacial system of baby during no nutrition is sucked, such as facial muscle tissus sensor 120.Yet this theme is applicable to other biological mechanics and electrophysiological research in addition.In some instances, each facial muscle tissus sensor 120 comprises at least one electrode.In an example, eight arrangement of electrodes become four bipolar right, these four bipolar four independent passages to orofacial system information that relevant baby is provided.For example, arbitrarily to 160A, 160B, 160C ..., between the 160N be constant at interval.In addition, in an example, by with 160A, 160B, 160C ..., 160N keeps at interval, eight electrodes are aligned to ring-type and closely cooperate with the curvature with baby's face.In an example, each such interval measurement is 4.5mm, and each electrode is the disk of 4mm diameter.In another example, can contain the 2mm offset of vertical with the electrode of baby's corners of the mouth linear array.In another example, at least one electrode is to be made up of gold at least in part.In also having another example, at least one electrode is made up of the material that comprises silver/silver chloride at least in part.Also can use other electrodes to form, and not break away from the scope of this theme.In other example, each electrode dopes CELLUVISC.CELLUVISC is the registered trade mark of the Allergan company limited (Irvine, CA 92623 for Allergan, Inc.) of California dust literary composition.This theme comprises that in addition other electrolyte solutions are with the ability of intensifier electrode detection from the EMG current potential of baby's all muscular tissue of mouth.

In a plurality of embodiments, as mentioned above, PC plate ring 156 holds eight and has electrode at interval, to detect baby's facial muscle tissue signal.In a plurality of embodiments, the gap size of electrode is adjustable with the size of the face that holds different babies.In an example, PC plate ring 156 comprises quick connection adapter 155, such as gold-plated plug receptacle adapter, so that the communication between facial muscle tissus sensor 120 and a plurality of facial muscle tissus sensor amplifier to be provided.

Fig. 5 A and 5B are the performance charts that illustrates the force feedback feature of motor during the on-the-spot no nutrition of premature infant is sucked.Particularly, force signal that is provided by force cell and the displacement signal that is provided by DVRT are provided respectively for Fig. 5 A and 5B.As mentioned above, in some instances, motor can with at least one stimulation device pick off, such as force cell or DVRT, integrate.As above further described, force cell provides force information with the form of motor 104 force signals, and DVRT provides positional information with the form of motor displacement signal.

In some instances, suck the information of sucking intensity, sucking the persistent period and sucking a kind of or its combination in the frequency that signal can comprise that the baby sucks.The curve chart of Fig. 6 A and 6B illustrates during no nutrition is sucked, processor receive from the baby suck signal the time analysis done.Particularly, Fig. 6 A illustrates the example that the expression baby sucks intensity and sucks the real-time pressure waveform of persistent period.Fig. 6 B illustrates the example that the expression baby sucks the real-time block diagram of frequency.

Baby's a biomechanics of orofacial system and an example of electrophysiological method during Fig. 7 illustrates research and sucks.This method comprises that detection represents 166 and will suck profile and represent to compare 168 with the predetermined profile of sucking from baby's the profile of sucking of sucking signal 162, detect current potential information 164 from baby's all muscular tissue of mouth, calculating the baby.In a plurality of examples, detection is sucked signal 162 and is comprised that the bag with false nipple inserts in baby's the mouth, such as before predetermined feeding (for example, 15 minutes before the feeding of being scheduled to).In some instances, detect and to suck signal 162 and comprise detecting and relevant with sucking of baby suck intensity, suck the persistent period and suck a kind of or its combination in the frequency.In some instances, detecting current potential information 164 comprises and utilizes at least one electrode.In an example, one or more electrodes are gold electrodes.In another example, one or more electrodes are silver/silver chloride electrodes.

In an example, method comprises applying to the baby stimulates 170.In a plurality of examples, method also comprise storage suck signal, current potential information, suck that profile is represented and the stimulation that applied in a kind of historical record 172 of or its combination.In a plurality of examples, method also comprise analyze or show suck signal, current potential information, suck that profile is represented and the stimulation that applied in a kind of or its combination with the active real-time expression of the oral area that the baby is provided.In some instances, apply stimulation 170 and comprise that the face to the baby provides or regulate mechanical stimulus.In an example, mechanical stimulus is included in linear displacement from about 10 milliseconds time cycle to baby's orofacial system that introduce one or more about 600-900 microns in.

This theme comprises the method for package system.In an example, method comprises the actinal surface pick off such as sucking pick off is connected with processor, and the one or more actinal surface pick offs such as the facial muscle tissus sensor are connected with processor.In some instances, method also comprises and will suck pick off and false nipple, such as the pneumatic connection of bag of false nipple.In some instances, method also comprises and being connected with receiver assembly sucking pick off.In some instances, method also comprises each facial muscle tissus sensor and electrode is integrated.

In a plurality of embodiments, method also comprises the stimulation control module is connected with processor.In a plurality of examples, method also comprises the stimulation device, is electrically connected with stimulating control module such as stimulation probe.In some instances, method also is included in integrated force feedback performance on the stimulation device.In an example, the stimulation device comprises motor, stimulates the utmost point and at least one stimulation device pick off.In some instances, method comprises a plurality of actinal surface pick offs, processor and stimulation device is installed in the device that being suitable for such as shell be connected with baby's actinal surface tissue.

Notice that preferably the parts to all systems that contact with the baby carry out disinfection.A kind of disinfection way in many disinfection way is to utilize oxirane.

This theme realized the baby of nervous function damage and dysplasia danger is arranged, such as the facial function of the nervi trigeminus of premature infant and suck biomechanics carry out Noninvasive, objectively and fast electrophysiology is assessed.These nervous function damages and dysplasia can comprise comprehensive development delay, sensation consciousness and comprehensive disorderly, sensorimotor malfunction, the cognitive function damage, literacy, literal and aphasis, hemorrhage, RD syndrome and oral area motion function obstacle.By in damage of the early stage diagnosis and treatment nervous function of baby's life and dysplasia, can be earlier for the baby adopt appropriate rectification activity, and therefore reduce or the function damage that elimination is found or the incidence rate or the seriousness of obstacle.In addition, utilize the baby of native system to compare, can have higher IQ with their companion who does not utilize this system.

In addition, system can be that the information how to be connected returns to the user with other parts of brain with the brain stem loop about the baby.System can be when sucking about the baby, and the baby is that the information of how to react is notified to the user, this information comprise baby's motor system tissue, suck, persistent period and frequency and the muscle reflection---all are presented on the display in real time.

Research

At present, normal full-term newborn infant is carried out sucking relevant biomechanics with no nutrition with clinical colony in the Neonatal Intensive Care Unit (" NICU ") and electrophysiological real-time sampling is studied.

Clinical colony among the NICU comprises the baby of experience RD syndrome, oral area motion function obstacle and cerebral infarction.Add up to 390 premature infants and will participate in the research in 4 years of reaching that finished in 2007.The NICU that participates in research comprises: in the Wei Er health center (Stormont-Vail Regional Health Center), area of Kansan Topeka and in University of Kansas's medical centre (Kansas UniversityMedical Center) of Kansan Kansas City.

Although in this diagram with described specific embodiment, those of ordinary skill in the art will be able to identify the specific embodiments of any layout that can reach same purpose as calculated shown in also alternative.The application intends to contain the modification or the variant of this theme.Be appreciated that it is illustrative that above description is intended, rather than restrictive.By the check foregoing description, the combination of above embodiment and other embodiments will be readily apparent to persons skilled in the art.The four corner of the equivalent that the scope of this theme should be authorized by reference claims and this claim is determined.

Claims

1. system comprises:

Bag;

A plurality of actinal surface pick offs are suitable for detecting at least one and suck signal and also be suitable for detecting at least one facial muscle tissue signal; And

Processor, at least one sucks signal and this at least one facial muscle tissue signal to be suitable for receiving this,

Wherein this processor is suitable for based on this at least one and sucks signal and this at least one facial muscle tissue signal and calculate and suck profile and represent.

2. the described system of claim 1, wherein at least one actinal surface pick off comprises electrode.

3. the described system of above-mentioned any one claim, further comprise with by the pneumatic first actinal surface pick off that is connected of the determined bag mouth of bag, this first actinal surface pick off is suitable for detecting sucks signal.

4. the described system of above-mentioned any one claim, wherein this first actinal surface pick off is a pressure converter.

5. the described system of above-mentioned any one claim, wherein this processor is suitable for utilizing at least in part this to suck that profile is represented and the profile of sucking of being scheduled to is calculated and sucked defective and represent.

6. the described system of above-mentioned any one claim, further comprise the stimulation control module that is suitable for providing boosting control signal, this boosting control signal is sucked defective based on this at least in part and is represented that wherein this boosting control signal is used to regulate or start the stimulation that offers this subject.

7. the described system of above-mentioned any one claim further comprises the stimulation device, and this stimulation device comprises the motor that is suitable for boosting control signal is converted to mechanical activity; And the stimulation utmost point that is mechanically connected to this motor, this stimulation utmost point is suitable for introducing this mechanical activity to the orofacial system of this subject.

8. the described system of above-mentioned any one claim, wherein this motor comprises that further at least one is suitable for providing a kind of in force signal and the displacement signal or both stimulation device pick offs.

9. the described system of above-mentioned any one claim, wherein this electrode is positioned at bag pedestal to detect the facial muscle tissue signal of this subject.

10. the described system of above-mentioned any one claim further comprises the receiver assembly between this bag and this first actinal surface pick off.

11. the described system of above-mentioned any one claim, further comprise at least one memory storage apparatus, this memory storage apparatus be suitable for storing this at least one suck signal, this at least one facial muscle tissue signal, this is sucked, and profile represents, sucks that defective is represented, the historical record of a kind of or its combination in boosting control signal, force signal and the displacement signal.

12. the described system of above-mentioned any one claim, further comprise display device, this display device be suitable for showing in real time bright this at least one facial muscle tissue signal, this suck profile represent, suck defective is represented and boosting control signal in a kind of or its combination.

13. a method comprises:

To suck pick off and be connected to bag;

This is sucked pick off be connected to shell;

At least one actinal surface pick off is connected to this shell;

Force feedback stimulation device is connected to this shell; And

In this shell, with processor and this stimulation device, this sucks pick off and this at least one actinal surface pick off is interconnected, this processor has memorizer.

14. the described method of claim 13 further comprises actinal surface pick off and electrode are integrated.

15. each described method among the claim 13-14 further comprises and will comprise motor, stimulate the assembly of the utmost point and at least one stimulation pick off to be connected to this processor.

16. each described method among the claim 13-15 further is connected to display this shell.

17. each described method among the claim 13-16 comprises that further data storage with pre-programmed is in this memorizer.

18. each described method among the claim 13-17, wherein the data of this pre-programmed comprise one or more profiles of sucking.